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Optimizing Vitamin D Status in Children With Wheeze / Asthma (OPTIVIT) (OPTIVIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02880930
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London

Tracking Information
First Submitted Date  ICMJE August 5, 2016
First Posted Date  ICMJE August 26, 2016
Last Update Posted Date April 8, 2019
Study Start Date  ICMJE December 2016
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
Proportion of children with vitamin D status above or equal to 75 nmol/L at 3 and 6 months of oral vitamin D3 supplementation [ Time Frame: 6 months in total ]
Proportion of children with asthma and pre-school wheezing illness with baseline serum 25(OH)D concentration<75 nmol/L attaining serum 25(OH)D concentration >75 nmol/L after 3 months of an oral daily dose of 400 IU and after an additional 3 months of oral daily vitamin D3 supplementation with 1,000 IU
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
  • Proportion of children with treatment related adverse events D status at 3 and 6 months of oral vitamin D3 supplementation [ Time Frame: 6 months in total ]
    To define the proportion of individuals with 25(OH)D concentration above 220nmol/L at 3 and 6 months after daily oral vitamin D3 supplementation.
  • Changes from baseline in concentration of inflammatory mediators in nasal epithelial lining fluid at 3 and 6 months after daily oral vitamin D3 supplementation [ Time Frame: 6 months in total ]
    To determine the effect of different regimens of oral vitamin D supplementation on concentrations of inflammatory mediators in nasal epithelial lining fluid (ELF) at 3 and 6 months
  • Changes from baseline in childhood Asthma Control Test at 3 and 6 months [ Time Frame: 6 months in total ]
    To determine the difference in childhood asthma control test score (c-ACT) at 3 months vs. 0 months and 6 months vs. 0 months for children ≥5 years.
  • Adherence to study supplement [ Time Frame: 6 months in total ]
    To determine the proportion of vitamin D3 supplementation doses taken (self-reported and supplement volume assessment) during the study
  • Capture of unscheduled health care attendances for asthma or wheezing illness (self-reported) [ Time Frame: 6 months in total ]
    To define the number of unscheduled healthcare attendances for asthma exacerbation(s) or wheezing illness as self-reported by individuals and their parents.
  • Capture of unscheduled health care attendances for asthma or wheezing illness [ Time Frame: 6 months in total ]
    To define the number of unscheduled healthcare attendances for asthma exacerbation(s) or wheezing illness as reported by GP records
  • Agreement between self-reported and GP record number of unscheduled healthcare visits [ Time Frame: 6 months in total ]
    To evaluate agreement between self-reported and GP record number of unscheduled healthcare attendance for wheezing illness or asthma exacerbation(s).
  • Determinants of vitamin D status [ Time Frame: 6 months in total ]
    To identify determinants of increase in serum 25(OH)D concentration in response to daily oral vitamin D3 supplementation
  • Participant's feedback about the study [ Time Frame: 6 months in total ]
    To evaluate children's and parents' experiences of taking part in the study (qualitative evaluation).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing Vitamin D Status in Children With Wheeze / Asthma (OPTIVIT)
Official Title  ICMJE Optimizing Vitamin D Status in Children With Pre-school Wheeze or Asthma:a Pilot Study (OPTIVIT)
Brief Summary Vitamin D deficiency is highly prevalent in the UK. Research shows that vitamin D enhances the immune system and may help protect against chest infections that can cause wheezing illness or worsen asthma symptoms. The Department of Health recommends a dose of 10 micrograms of vitamin D/day to prevent severe vitamin D deficiency in children. However, many studies have reported that this dose is not enough to raise plasma 25(OH)D concentration to the levels most likely to prevent against worsening of asthma symptoms. Such studies suggest that 25 micrograms of vitamin D/day. This dose is safe but its effects on vitamin D blood levels have not yet been specifically tested in children with asthma/wheeze. This study is designed to determine the optimal oral daily vitamin D supplementation dose to treat vitamin D deficiency in children with asthma or preschool wheeze. Over the 6-month course of the study, participants will meet with the study team four times in clinic or in their own home and will be contacted by telephone five times. Children will be asked to give a drop of blood via a fingerprick to test their vitamin D level and a sample of nasal epithelial lining fluid for measurement of inflammatory markers on three separate occasions.
Detailed Description

The study is designed to compare the efficacy of a daily oral vitamin D3 supplementation dose of 10 micrograms (400 IU) for 3 months vs a daily oral vitamin D3 supplementation dose of 25 micrograms (1,000 IU) for an additional 3 months in correcting vitamin D deficiency in children with asthma or preschool wheezing illness.

Identification procedures

A member of the patient's usual care team will identify potentially eligible participants from patient records at participating sites. Identified individuals will be contacted by post, giving a brief explanation of the study and asking them to contact a member of the research team if they wish to find out more. A member of the research team will explain the study to them and ask them if they would like to receive the study participant information sheet (PIS). The PIS will be posted to patients expressing an interest in the study; those who subsequently confirm their interest in participation will be re-contacted by the study team, and offered a screening appointment at a study site. Additionally, posters advertising the study and providing contact details for the study team will be displayed in appropriate public places, such as hospital out-patient departments and General Practitioner (GP) surgeries, where potentially eligible participants are likely to see them; advertisements for the study may also be placed in the press, and circulated on email within Queen Mary, University of London. Potentially eligible children who fulfill eligibility criteria and give their assent (if aged ≥7 years) and have consent from their parent/legal guardian will be enrolled in the study.

Study visits

Visit 1 - Screening:

Once the child and their parent/legal guardian decide to take part in the study and sign the agreement forms (assent and consent form), the investigators will record details of children's sociodemographic status, ethnicity, age and sex. The investigators will measure children's body weight and height, and ask children aged >= 5 years to fill in a questionnaire to assess their level of asthma symptom control. The investigators will then collect a drop of each child's blood with a finger-prick to measure his/her vitamin D level and a sample of fluid from one nostril of each child with a small (5 x 25 mm) strip of absorbent material to measure his/her inflammatory status. The investigators will apply a numbing cream or spray to each child's finger before the fingerprick to minimise discomfort.

Telephone contact T1:

The investigators will telephone children's parents/legal guardians to let them know the results of their child's baseline vitamin D test. If this is normal (75 nmol/L or more), then the child does not need a vitamin D supplement: the parent / guardian will be reassured, and the child will not be able to take part in this study. If the level is low, then the investigators will arrange to meet with the child and his/her parent/guardian a second time.

Visit 2 - (1 week later):

At this visit, the investigators will show children's parents/legal guardians how to give their child the study drops each day and also supply them with a bottle of vitamin D drops for their child to take every day at a dose of 6 drops (400 IU; 10 μg) per day. The investigators will also give them a diary where they can record the doses their child takes every day and note down details of unplanned visits to a doctor/nurse due to wheezing illness or worsening of asthma symptoms during the study.

Telephone contact T2 - (One week after Visit 2):

The investigators will telephone parents/legal guardians as arranged to check if their child is taking the study drops and to see how they are getting on. The investigators will also check if their child has made any unplanned visits to a doctor or a nurse due to wheezing illness or worsening of asthma symptoms since the last study visit.

Telephone contact T3 - (Three weeks after telephone call T2):

In this telephone call, the investigators will make the same checks as those in telephone contact T2.

Visit 3 - (Month 3):

In this visit, the investigators will perform the same tests as those in study visit 1. The investigators will take back the bottle with the remaining vitamin D liquid and the completed study diary, and provide a new diary and bottle with study drops.

Telephone contact T4 - (One week after Visit 3):

In this telephone call, the investigators will do the same checks as those in telephone call T2. The investigators will also let parents/legal guardians know results of their child's second vitamin D test. Based on this result, the investigators will decide if their child needs to increase the dose to 15 drops (1,000 IU; 25 μg) per day for a further 3 months or to continue with 6 drops (400 IU; 10 μg) per day for a further 3 months or to stop vitamin D supplementation.

Telephone contact T5 - (Three weeks after telephone call T4):

In this telephone call, the investigators will make the same checks as those in telephone contact T2.

Visit 4 - FINAL VISIT - (Month 6):

In this study visit, the investigators will perform the same tests as those in study visit 1. The investigators will ask parents/legal guardians to complete a final questionnaire about their child's experience in the study. The investigators will take back the bottle with the remaining study drops and the completed study diary. Once enrolment to the study and analysis of all study data is complete, the investigators will write to participants' parents/legal guardians to tell them about our final findings, including results of their child's final vitamin D test.

Additional procedures throughout the study:

Participants' parents/legal guardians will be asked to report the daily supplementation doses their child takes and record details of unplanned healthcare visits to a GP/nurse due to wheezing illness or worsening of asthma symptoms during the study.

If a participant reports symptoms of raised blood calcium level during the study nausea, vomiting or feeling generally unwell), an urgent check of his/her corrected blood calcium level will be performed and an appointment with a pediatrician will be arranged if necessary.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Asthmatic Crisis
  • Wheezing
Intervention  ICMJE Dietary Supplement: Fultium-D3 drops (Internis)
Oral daily doses of vitamin D3 (400 IU for 3 months; and 1,000 IU for an additional 3 months)
Study Arms  ICMJE Experimental: Vitamin D supplement (Cholecalciferol)
Participants will be given oral Fultium-D3 drops (Internis) contain 400 IU cholecalciferol/day for a period of 3 months. Daily vitamin D3 supplementation dose will be increased to 1,000 IU for an additional 3 months if plasma 25(OH)D still below 75 nmol/L.
Intervention: Dietary Supplement: Fultium-D3 drops (Internis)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children aged 1-12 years

    • For children aged 1-4 years: ≥2 self-reported wheezing illness episodes (as shown in a video recording of a wheeze episode) requiring unscheduled healthcare in the previous year
    • For children aged 5-12 years: doctor diagnosis of asthma and ≥1 self-reported asthma exacerbation requiring an unscheduled healthcare visit in the previous year.
  • Children's parent/legal guardian gives informed consent for children.
  • If child aged ≥7 years, gives informed assent.

Exclusion Criteria:

  • Baseline 25(OH)D concentration ≥75 nmol/L.
  • Already taking any vitamin D supplements.
  • Any other chronic or recent acute respiratory or systemic condition.
  • Already enrolled in another interventional research study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02880930
Other Study ID Numbers  ICMJE 011320
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Queen Mary University of London
Study Sponsor  ICMJE Queen Mary University of London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adrian Martineau Barts and The London School of Medicine and Dentistry, Queen Mary University, University of London
PRS Account Queen Mary University of London
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP